Dr. Sergey Maksin

Project Management (Global outsourced clinical trials) responsibilities. Key client contact for assigned projects. Monitoring project scope, schedule and costs to ensure all remain on track with the contract and with financial performance targets. Ensuring effective cross-functional teamwork among project team members including both internal and external stakeholders.

Clinical Trials Management (Global outsourced clinical trials): Clinical Trial planning and setup, Clinical Trial oversight through all study phases according to the contractual agreement; Clinical Trial progress reporting to the department study management; Development and coordination of preventive/mitigation actions for identified risks and study challenges; Providing input to trial related documents and processes development.

Clinical Trials Management (Global and local outsourced clinical trials): Standard operational clinical trials management activities from feasibility, study planning and oversight to study closure; Sites budget development, negotiation and setup for local studies, CRO site budget proposals review for globally outsourced studies; Sponsor Investigational Sites Liaison; Landscape and Feasibility Expertise; CRAs and junior department staff training and couching.

All aspects of Clinical Trials monitoring activities (Feasibility, Start – Up, Initiation, Site management, Monitoring and Close – Out activities).

Training and consulting: GxP, SOPs, QM/QA trainings for Investigators and CRO staff; Training programs development according to the CRO/SMO requirements; Clinical Trials consulting in the area of QM/QA and Risk Management (SOPs review); Audits and Inspections preparation; Business development activities, contracts negotiation.

Quality management: Assessment of department staff performance; Co – monitoring visits with CRAs, TMF review, SOPs review; Preparation for audits/inspections, audits/inspections findings assessment, corrective and preventive actions development and implementation; Quality risks and issues identification and resolution; Training programs development and implementation; GCP trainings for department staff and Investigators; LMS maintenance; Local SOPs writing and review.

All aspects of Clinical Trials monitoring activities (Feasibility, Start – Up, Initiation, Site management, Monitoring and Close – Out activities).

All aspects of Clinical Trials monitoring activities (Feasibility, Start – Up, Initiation, Site management, Monitoring and Close – Out activities).

Patients treatment; HealthCare organization and planning activities;